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21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. ​

文献信息 ​

DOI10.1056/NEJMoa2108873
PMID34914339
期刊The New England journal of medicine
影响因子78.5
JCR 分区Q1
发表年份2021
被引次数364
关键词21基因检测, 化疗益处, 淋巴结阳性乳腺癌
文献类型Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
ISSN0028-4793
页码2336-2347
期号385(25)
作者Kevin Kalinsky, William E Barlow, Julie R Gralow, Funda Meric-Bernstam, Kathy S Albain, Daniel F Hayes, Nancy U Lin, Edith A Perez, Lori J Goldstein, Stephen K L Chia, Sukhbinder Dhesy-Thind, Priya Rastogi, Emilio Alba, Suzette Delaloge, Miguel Martin, Catherine M Kelly, Manuel Ruiz-Borrego, Miguel Gil-Gil, Claudia H Arce-Salinas, Etienne G C Brain, Eun-Sook Lee, Jean-Yves Pierga, Begoña Bermejo, Manuel Ramos-Vazquez, Kyung-Hae Jung, Jean-Marc Ferrero, Anne F Schott, Steven Shak, Priyanka Sharma, Danika L Lew, Jieling Miao, Debasish Tripathy, Lajos Pusztai, Gabriel N Hortobagyi

一句话小结 ​

本研究探讨了复发评分对激素受体阳性、HER2阴性、腋窝淋巴结阳性乳腺癌患者化疗获益的影响，发现绝经前女性在接受化疗内分泌治疗时，其侵袭性无病生存期和远处无复发生存期显著提高，而绝经后女性则未见化疗获益。这一发现为个体化治疗策略提供了重要依据，强调了在不同绝经状态下对化疗策略的差异化应用。

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21基因检测 · 化疗益处 · 淋巴结阳性乳腺癌

摘要 ​

背景
基于21基因乳腺癌检测的复发评分在预测激素受体阳性、HER2阴性、腋窝淋巴结阴性乳腺癌患者的化疗获益方面具有临床实用性。在淋巴结阳性女性中，复发评分在预测辅助化疗获益方面的作用尚不明确。

方法
在一项前瞻性试验中，我们随机分配了患有激素受体阳性、HER2阴性乳腺癌的女性，且具有1至3个阳性腋窝淋巴结及复发评分为25或更低（评分范围为0至100，分数越高预后越差），接受单纯内分泌治疗或化疗加内分泌治疗（化疗内分泌治疗）。主要目标是确定化疗对侵袭性无病生存期的影响，以及复发评分是否会影响该效果。次要终点包括远处无复发生存期。

结果
共5083名女性（33.2%为绝经前，66.8%为绝经后）参与了随机分配，其中5018名参与了试验。在预先设定的第三个中期分析中，化疗在提高侵袭性无病生存期方面的获益因绝经状态而异（绝经前与绝经后参与者的化疗获益比较，P=0.008），并进行了单独的预设分析。在绝经后女性中，内分泌单独治疗组的5年侵袭性无病生存率为91.9%，而化疗内分泌治疗组为91.3%，未见化疗获益（侵袭性疾病复发、新原发癌（乳腺癌或其他类型）或死亡的风险比为1.02；95%置信区间[CI]，0.82至1.26；P=0.89）。在绝经前女性中，内分泌单独治疗的5年侵袭性无病生存率为89.0%，而化疗内分泌治疗为93.9%（风险比为0.60；95% CI，0.43至0.83；P=0.002），远处无复发生存率也有类似的增加（风险比为0.58；95% CI，0.39至0.87；P=0.009）。随着复发评分的增加，相对化疗获益并未增加。

结论
在具有1至3个阳性淋巴结且复发评分为25或更低的绝经前女性中，接受化疗内分泌治疗的患者相比于接受单纯内分泌治疗的患者具有更长的侵袭性无病生存期和远处无复发生存期，而具有相似特征的绝经后女性则未从辅助化疗中获益。（研究由国家癌症研究所及其他机构资助；RxPONDER临床试验注册号，NCT01272037。）

英文摘要 ​

BACKGROUND The recurrence score based on the 21-gene breast-cancer assay has been clinically useful in predicting a chemotherapy benefit in hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary lymph-node-negative breast cancer. In women with positive lymph-node disease, the role of the recurrence score with respect to predicting a benefit of adjuvant chemotherapy is unclear.

METHODS In a prospective trial, we randomly assigned women with hormone-receptor-positive, HER2-negative breast cancer, one to three positive axillary lymph nodes, and a recurrence score of 25 or lower (scores range from 0 to 100, with higher scores indicating a worse prognosis) to endocrine therapy only or to chemotherapy plus endocrine (chemoendocrine) therapy. The primary objective was to determine the effect of chemotherapy on invasive disease-free survival and whether the effect was influenced by the recurrence score. Secondary end points included distant relapse-free survival.

RESULTS A total of 5083 women (33.2% premenopausal and 66.8% postmenopausal) underwent randomization, and 5018 participated in the trial. At the prespecified third interim analysis, the chemotherapy benefit with respect to increasing invasive disease-free survival differed according to menopausal status (P = 0.008 for the comparison of chemotherapy benefit in premenopausal and postmenopausal participants), and separate prespecified analyses were conducted. Among postmenopausal women, invasive disease-free survival at 5 years was 91.9% in the endocrine-only group and 91.3% in the chemoendocrine group, with no chemotherapy benefit (hazard ratio for invasive disease recurrence, new primary cancer [breast cancer or another type], or death, 1.02; 95% confidence interval [CI], 0.82 to 1.26; P = 0.89). Among premenopausal women, invasive disease-free survival at 5 years was 89.0% with endocrine-only therapy and 93.9% with chemoendocrine therapy (hazard ratio, 0.60; 95% CI, 0.43 to 0.83; P = 0.002), with a similar increase in distant relapse-free survival (hazard ratio, 0.58; 95% CI, 0.39 to 0.87; P = 0.009). The relative chemotherapy benefit did not increase as the recurrence score increased.

CONCLUSIONS Among premenopausal women with one to three positive lymph nodes and a recurrence score of 25 or lower, those who received chemoendocrine therapy had longer invasive disease-free survival and distant relapse-free survival than those who received endocrine-only therapy, whereas postmenopausal women with similar characteristics did not benefit from adjuvant chemotherapy. (Funded by the National Cancer Institute and others; RxPONDER ClinicalTrials.gov number, NCT01272037.).

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主要研究问题 ​

  1. 在不同的荷尔蒙受体状态下，21基因检测的预测能力是否存在差异？
  2. 除了化疗和内分泌治疗，是否还有其他治疗方案可以改善节点阳性乳腺癌患者的预后？
  3. 在临床试验中，如何评估21基因检测结果对患者治疗决策的影响？
  4. 针对有不同复发评分的患者，化疗的适应症和疗效是否存在显著差异？
  5. 研究结果对未来乳腺癌治疗指南的影响是什么，尤其是在节点阳性患者群体中？

核心洞察 ​

研究背景和目的 ​

在激素受体阳性、HER2阴性、腋窝淋巴结阴性的乳腺癌患者中，基于21基因乳腺癌检测的复发评分在预测化疗益处方面具有临床价值。然而，对于淋巴结阳性患者，复发评分在预测辅助化疗的益处方面的作用尚不明确。本研究旨在评估在具有一至三个阳性腋窝淋巴结且复发评分为25或以下的激素受体阳性、HER2阴性乳腺癌女性中，化疗对侵袭性无病生存率的影响。

主要方法/材料/实验设计 ​

本研究为前瞻性试验，随机分配参与者接受内分泌治疗或化疗加内分泌治疗（化疗内分泌治疗）。主要目标是确定化疗对侵袭性无病生存率的影响，并评估复发评分对该影响的调节作用。次要终点包括远处复发无生存率。

Mermaid diagram

关键结果和发现 ​

  • 5083名女性参与随机分配，其中5018名参与了试验。
  • 第三次中期分析显示，化疗对侵袭性无病生存率的益处因绝经状态而异（P=0.008）。
  • 在绝经后女性中，5年侵袭性无病生存率为91.9%（内分泌组）和91.3%（化疗内分泌组），未显示化疗益处（风险比1.02，95% CI 0.82-1.26，P=0.89）。
  • 在绝经前女性中，5年侵袭性无病生存率为89.0%（内分泌组）和93.9%（化疗内分泌组），化疗显示出显著益处（风险比0.60，95% CI 0.43-0.83，P=0.002），远处复发无生存率也有类似改善（风险比0.58，95% CI 0.39-0.87，P=0.009）。
  • 随着复发评分的增加，化疗的相对益处并未增加。

主要结论/意义/创新性 ​

对于一至三个阳性腋窝淋巴结且复发评分为25或以下的绝经前女性，化疗内分泌治疗相较于内分泌治疗能显著提高侵袭性无病生存率和远处复发无生存率。然而，绝经后女性在相似条件下并未从辅助化疗中获益。本研究的结果提示了绝经状态在化疗决策中的重要性，并为临床实践提供了指导。

研究局限性和未来方向 ​

  • 本研究的局限性包括仅在特定人群中进行，结果可能不适用于其他类型的乳腺癌患者。
  • 未来的研究应进一步探讨复发评分与其他生物标志物结合的潜在作用，以优化化疗决策，并探索不同治疗组合的效果。

参考文献 ​

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引用本文的文献 ​

  1. The incidence of discordant clinical and genomic risk in patients with invasive lobular or ductal carcinoma of the breast: a National Cancer Database Study. - Mary Kathryn Abel;Amy M Shui;Michelle Melisko;A Jo Chien;Emi J Yoshida;Elizabeth M Lancaster;Laura Van 't Veer;Laura J Esserman;Rita A Mukhtar - NPJ breast cancer (2021)
  2. Gene Expression Profiling in Early Breast Cancer-Patient Stratification Based on Molecular and Tumor Microenvironment Features. - Gyöngyi Munkácsy;Libero Santarpia;Balázs Győrffy - Biomedicines (2022)
  3. Therapeutic Targeting of Minimal Residual Disease to Prevent Late Recurrence in Hormone-Receptor Positive Breast Cancer: Challenges and New Approaches. - David W Cescon;Kevin Kalinsky;Heather A Parsons;Karen Lisa Smith;Patricia A Spears;Alexandra Thomas;Fengmin Zhao;Angela DeMichele - Frontiers in oncology (2021)
  4. A Canadian national guideline on the neoadjuvant treatment of invasive breast cancer, including patient assessment, systemic therapy, and local management principles. - Sonal Gandhi;Muriel Brackstone;Nicole J Look Hong;Debjani Grenier;Elysia Donovan;Fang-I Lu;Mia Skarpathiotakis;Justin Lee;Jean-Francois Boileau;Francisco Perera;Christine Simmons;Anil A Joy;William T Tran; - Breast cancer research and treatment (2022)
  5. A prediction model for early systemic recurrence in breast cancer using a molecular diagnostic analysis of sentinel lymph nodes: A large-scale, multicenter cohort study. - Tomo Osako;Masaaki Matsuura;Daisuke Yotsumoto;Shin Takayama;Koji Kaneko;Mina Takahashi;Kenzo Shimazu;Katsuhide Yoshidome;Kazuya Kuraoka;Masayuki Itakura;Mayumi Tani;Takashi Ishikawa;Yasuyo Ohi;Takayuki Kinoshita;Nobuaki Sato;Masahiko Tsujimoto;Seigo Nakamura;Hitoshi Tsuda;Shinzaburo Noguchi;Futoshi Akiyama - Cancer (2022)
  6. Oncotype DX Recurrence Score in premenopausal women. - Shiliang Zhang;Kasey C Fitzsimmons;Sara A Hurvitz - Therapeutic advances in medical oncology (2022)
  7. The Role of the 21-Gene Recurrence Score® Assay in Hormone Receptor-Positive, Node-Positive Breast Cancer: The Canadian Experience. - Mariya Yordanova;Saima Hassan - Current oncology (Toronto, Ont.) (2022)
  8. Feasibility of Adjuvant Treatment with Abemaciclib-Real-World Data from a Large German Breast Center. - Dominik Dannehl;Lea L Volmer;Martin Weiss;Sabine Matovina;Eva-Maria Grischke;Ernst Oberlechner;Anna Seller;Christina B Walter;Markus Hahn;Tobias Engler;Sara Y Brucker;Andreas D Hartkopf - Journal of personalized medicine (2022)
  9. Benefits of Adjuvant Chemotherapy Differ by Menopausal Status in Women with HR+/HER2- Early Breast Cancer, 1-3 Positive Nodes, and a Low Recurrence Score. - Anne Jacobson - The oncologist (2022)
  10. Are we closer to being able to select patients with node-positive hormone receptor-positive breast cancer who can safely omit chemotherapy? - Caitlin Taylor;Jane Meisel;Kevin Kalinsky - Therapeutic advances in medical oncology (2022)

... (354 更多 篇文献)

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